NCT06924593 Study on the Trans-Carotid Artery Occlusion Shunt System
| NCT ID | NCT06924593 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shenzhen Wecan Medical Technology Co.,Ltd |
| Condition | Revascularization |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2025-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment
Eligibility Criteria
Inclusion Criteria: * Age \> 18 years; * For patients diagnosed with carotid artery stenosis and planned to undergo transcarotid artery endovascular revascularization, one of the following conditions must be met: 1. Symptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \> 50%, and the patient has a history of stroke (mild or non-disabling), transient ischemic attack (TIA), and/or amaurosis fugax within 180 days before the operation. 2. Asymptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \> 70%, and the patient has not experienced any neurological symptoms within 180 days before the operation. * The modified Rankin Scale (mRs) score ≤ 2 before enrollment. * The patient must meet at least one of the following important anatomical or comorbid high-risk conditions in order to be included in the study: Anatomical high-risk: A. Contralateral carotid artery occl